Technology Supported Education Program Based on Human Care Theory

NCT05438823 | Completed

• 1 other identifier: Akdenizuni
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hematopoietic stem cell transplantation is applied in the childhood age group for many reasons such as hematological malignancies, immune deficiencies, hemoglobinopathies, bone marrow failures and congenital metabolic diseases. The transplantation process, which requires a long hospitalization process, is an experience that causes anxiety for the child and the caregiver.

Conditions

Stem Cell Transplantation; Nursing Caries

Keywords

caregiver; parent; stem cell transplantation; self-efficacy; quality of life; theory of human caring

Outcome Measures

Primary Outcomes (4)

• Knowledge

  There are 13 questions in the questionnaire prepared in line with the literature. The questions will be answered as "strongly agree", "agree", "undecided", "disagree", "strongly disagree".

  1 year

• Self-Efficacy

  Generalized Self-Efficacy Scale, developed by Schwarzer and Jarusalem (1995) and validated in Turkish by Aypay (2010), consists of 10 items in total. The response category is a 4-point scale and is scored as "Totally wrong = 1 point", "Slightly correct = 2 points", "Moderately correct = 3 points", "Totally correct = 4 points". There is no inverse item and cut-off point in the scale. The lowest 10 and the highest 40 points are taken from the scale. It is interpreted as "perceived self-efficacy increases as the scale score increases".

  1 year

• Quality Life

  The Caregiver Quality of Life Index Cancer Scale (CQOLC), developed by Weitzner et al. (1999), aims to measure caregivers' quality of life, including their physical, emotional, familial and social functions. The total score of each sub-dimension and scale in the scale ranges from 0 to 140. In the scale, financial distress, discomfort sub-dimensions and some questions consist of reversed statements. The scale contains a total of 35 items.

  1 year

• Anxiety

  It consists of 2 subscales, namely state and trait anxiety. State Anxiety Sub-Scale (STAI-S), an individual's at a certain time and under certain conditions; The Trait Anxiety Subscale (STAI-T) usually requires a description of how one feels. The inventory is answered via 4-point scales. The emotions and behaviors expressed in the items of the State Anxiety Sub-Scale are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. Emotions and behaviors expressed in Trait Anxiety Sub-Scale items are according to their frequency levels; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always.

  1 hyear

Secondary Outcomes (1)

• Patient Satisfaction Evaluation Form According to Watson Improvement Processes

  1 year

Study Arms (2)

İntervention group

EXPERIMENTAL

The sample of the study will be the parents of children who have had hematopoietic stem cell transplantation at Akdeniz University Hospital and whose discharge is planned (n=20).

Other: Educational Programe

Control group

NO INTERVENTION

The control group will be the parents of children who underwent hematopoietic stem cell transplantation at Akdeniz University Hospital and are planned to be discharged (n=20). Participants in this group will receive routine care, and at the end of the study, training program will be applied.

Interventions

Educational Programe OTHER

IBK-EBP will be administered to parents in six sessions in six days. After six days of training, the mobile application will be used by parents for 8 weeks. The frequency of use of the mobile application will be left entirely to the needs of the parents and reminders will be made through the mobile application. In addition, the video used during the face-to-face training, progressive relaxation exercise videos and motivational sentences will also be included in the mobile application.

İntervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care parent of the child (0-18 years old) after HSCT
• Having mobile internet access
• Discharge planned

You may not qualify if:

• Parent's failure to attend at least 3 sessions of the training program

Sponsors & Collaborators

• Akdeniz University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Study Officials

• Emine EFE, Proff.Dr.

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 30, 2022
• Study Start: February 3, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)